NL-OMON47662
Completed
Phase 3
A study to assess the renoprotective effects of the SGLT2 inhibitor Dapagliflozin in non-diabetic patients with proteinuria: a randomized double blind 6-week cross-over trial - The effects of dapagliflozin in non-diabetic patients with proteinuria
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversitair Medisch Centrum Groningen
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Age \*18 and \*75 years
- •\- Urinary protein excretion \> 500 mg/g and \* 3500 mg/g in a 24\-hr urine collection
- •\- eGFR \* 25 mL/min/1\.73m2
- •\- On a stable dose of an ACEi or ARB for at least 4 weeks prior to randomization
- •\- Willing to sign informed consent
- •\- Women of Child\-Bearing Potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of study drug in such a manner that the risk of pregnancy is minimized.
- •\- WOCBP must have a negative serum or urine pregnancy test result (minimum sensitivity 25 IU/L or equivalent units of HCG) within 0 to 72 hours before the first dose of study drug.
- •\- Women must not be breast\-feeding
Exclusion Criteria
- •\- Diagnosis of type 1 or type 2 diabetes mellitus
- •\- Urinary protein excretion \> 3500 mg/day
- •\- Peripheral Vascular Disease
- •\- Autosomal dominant polycystic kidney disease or autosomal recessive polycystic kidney disease, lupus nephritis, or ANCA\-associated vasculitis
- •\- Indication for immunosuppressants as per the treating physician\*s judgment.
- •\- Receiving cytotoxic therapy, immunosuppressive therapy, or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment.
- •\- Active malignancy aside from treated squamous cell or basal cell carcinoma of the skin.
- •\- Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following:
- •o History of active inflammatory bowel disease within the last six months;
- •o Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
Outcomes
Primary Outcomes
Not specified
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